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Napiers Herbal Slimming Aid

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Napiers Herbal Slimming Aid Slimwell Herbal Slimming Tablets Quantrim Herbal Slimming Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:-

40 mg of extract (as dry extract) from Bladderwrack (Fucus vesiculosus L.) (5:1) (equivalent to 200 mg of Bladderwrack)

Extraction solvent: Water

50 mg of extract (as dry extract) from Clivers (Galium aparine L.) (4:1) (equivalent to 200 mg of Clivers)

Extraction solvent: Water

Each tablet contains 61.8 mg of sucrose. (See section 4.4 ‘Special warnings and precautions for use’.)

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablets.

White glossy round, convex, unscored tablet.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used as an aid to slimming as part of a calorie controlled diet, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults over 18 years of age: Two tablets to be taken three times daily after meals.

This product must be used in conjunction with a calorie controlled diet and exercise.

If symptoms do not improve or worsen during the use of this product, a doctor or qualified healthcare professional should be consulted.

The use in children and adolescents under the age of 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).

4.3 Contraindications

Hypersensitivity to Fucus (Bladderwrack), Clivers or any of the excipients. Patients with a thyroid disorder.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

The use in children and adolescents under 18 years of age is not recommended because data are insufficient and medical advice should be sought.

This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

No studies have been carried out to determine if drug reactions occur with this product.

This product can theoretically have an effect on anticoagulant treatments. Patients taking anticoagulant treatments should not use this product.

4.6 Fertility, Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during pregnancy and lactation is not recommended.

Studies on fertility have not been carried out.

4.7    Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been conducted.

4.8    Undesirable effects

None known.

If adverse reactions occur a doctor or qualified health care practitioner should be consulted.

4.9    Overdose

No cases known.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2    Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3    Preclinical safety data

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Tricalcium Phosphate

Sucrose

Acacia (E414)

Talc (E553(b))

Maize Starch Stearic Acid Shellac (E904)

Kaolin Heavy (E559) Titanium Dioxide (E171) Kaolin Light (E559)

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

Three years.

6.4    Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5    Nature and contents of container

Plastic pot with tamper-proof closure, or amber glass bottle with bakelite-type screw-cap packed in a cardboard carton: 100 tablets.

6.6    Special precautions for disposal

No special requirements.

7


MARKETING AUTHORISATION HOLDER

Highland Herbs Limited 10 Payne Street Glasgow G4 0LF

8    MARKETING AUTHORISATION NUMBER(S)

THR 43751/0022

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

08/11/12

10 DATE OF REVISION OF THE TEXT

30/01/2015